| Protocol ID | NCT05605574 |
| Registration Date | 2022-11-04 |
| Status | recruiting |
| Sponsor | National Cancer Institute (NCI) |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2022-11-16 |
| Last Patient Out | 2026-12-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 120 Years |
NCT05605574
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
| Field |
OPENAI
gpt-4o Thinking: o3 3439ms / 9760 tok |
GLM
glm-5.1 7718ms / 9938 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5291ms / 11365 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
inpatient
mixed → inpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: inpatient — The study involves patients undergoing allogeneic hematopoietic stem cell transplantation, a procedure that typically requires hospitalization.
|
inpatient |
inpatient
inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — Patients are undergoing hematopoietic stem cell transplantation (HSCT) which requires hospitalization and continuous monitoring during the treatment period.
|
OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | yes | yes | yes | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
yes
yes → yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The study involves a SUPPORTIVE_CARE purpose with advance care planning discussions related to patient-centered care, which aligns with palliative care services.
Thinking: yes — The intervention consists of advance care planning conversations as a supportive-care communication program, which constitutes a palliative care service rather than a pharmacologic or disease-directed treatment.
|
yes |
no
no → yes → no
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The intervention is advance care planning (ACP) conversations and documentation, which is a core component of palliative care service delivery focused on goals of care discussions and care planning.
Thinking: no — The intervention being tested is advance care planning (ACP) conversations using structured guides, not palliative care consultation, referral, or service delivery itself.
|
|
| intervention_education |
yes
yes → yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The primary component of the trial involves guided discussions and education about advance care planning, which is an educational intervention for patients and caregivers.
Thinking: yes — The main intervention is a series of structured conversations that teach and guide patients/caregivers through advance care-planning materials, making patient/caregiver education the primary focus.
|
no |
no
no → yes → no
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The intervention consists of structured educational conversations teaching patients and caregivers about advance care planning topics and guiding them through completing the Voicing My CHOiCES advance care planning document, which is primarily educational in nature.
Thinking: no — The intervention primarily consists of facilitated advance care planning conversations to elicit and document patient values and preferences, not educational or training programs.
|
|
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |